BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4161875 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19421
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PATIENT¿S RECHARGE LOG WAS REVIEWED, IT SHOWED THAT THE PATIENT HAD NOT RECHARGED SINCE (B)(6) 2013, WHICH DID NOT MATCH WHAT THE PATIENT WAS CLAIMING, WHICH WAS THAT SHE HAD RECHARGED HER DEVICE A COUPLE DAYS BEFORE THE NOTIFIED DATE. THE PATIENT WAS TOLD THAT SHE WOULD NEED TO DO A PHYSICIAN MODE RECHARGE (PMR) BUT THE PATIENT DID NOT HAVE ENOUGH TIME TO DO THAT THAT DAY. THE PATIENT WAS GIVEN THE MANUFACTURING REPRESENTATIVE¿S NUMBER AND WAS TO CALL THE MANUFACTURING REPRESENTATIVE FOR A PMR INITIATION. THE PATIENT HAD NOT CONTACTED THE MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THERE WAS NO PARTICULAR MANAGING HEALTHCARE PROVIDER (HCP) FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING STIMULATION SENSATION. THIS HAD OCCURRED FOR 3-4 DAYS PRIOR TO THIS REPORT. IT WAS STATED THAT THE BATTERY WAS FULLY CHARGED. SYNCHING WAS ATTEMPTED AND THE PATIENT GOT THE NO COMMUNICATION SCREEN. THIS WAS DONE AGAIN WITHOUT THE ANTENNA AND STILL GOT THE NO COMMUNICATION SCREEN. TELEMETRY ISSUES WERE REPORTED. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER (PP), THE INS RECHARGER (INSR), AND THE CLINICIAN PROGRAMMER. CHARGING HAD BEEN DONE ON THE WEDNESDAY OR THURSDAY PRIOR TO THIS REPORT AND WAS GETTING 3 COUPLING BARS. USUALLY SHE WOULD GET ALL 8. STIMULATION WAS WORKING FINE UP UNTIL 3 DAYS PRIOR TO THIS REPORT. EVERYTHING WAS THEN NOTED TO SHUT OFF WITH NO STIMULATION. RECHARGING STATISTICS WERE ANALYZED AND THE LAST RECHARGING SESSION WAS ON (B)(6) 2013. NO DATE STAMP APPEARED FOR THE WEEK PRIOR TO THIS REPORT OR THAT TIMEFRAME. THE PATIENT ONLY HAD THIS ONE RECHARGER. A PHYSICIAN RECHARGE MODE WAS SUGGESTED. FOLLOW-UP WAS CONDUCTED TO DETERMINE IF AN OVERDISCHARGE WAS CONFIRMED, IF ANY INTERVENTION OCCURRED, AND IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640496 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1